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Nova Biomedical Corporation FDA Recalls
10 recalls on file across devices, 8 of them Class I and 10 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| StatStrip Glucose Hospital Meter System. Model No: 66739. Glucose test system.Class IJul 29, 2026A software synchronization/timing issue in the barcode scann |
| StatStrip Glucose and B- Ketone meter. Model No: 66429. Glucose test system.Class IJul 29, 2026A software synchronization/timing issue in the barcode scann |
| StatStrip Glucose and B- Ketone meter. Model No: 63910. Glucose test system.Class IJul 29, 2026A software synchronization/timing issue in the barcode scann |
| StatStrip Glucose and B- Ketone meter. Model No: 63683. Glucose test system.Class IJul 29, 2026A software synchronization/timing issue in the barcode scann |
| StatStrip Glucose Hospital Meter System. Model No: 63685. Glucose test system.Class IJul 29, 2026A software synchronization/timing issue in the barcode scann |
| StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patiClass INov 20, 2024A software bug within the Gen 2 StatStrip Hospital Meter fir |
| StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number: 63910. Prescription use blood glucose ketClass INov 20, 2024A software bug within the meter firmware leads to transmissi |
| StatStrip Glucose Ketone Hospital Meter System. Model/Catalog Number: 63683. Prescription use blood glucose ketone meterClass INov 20, 2024A software bug within the meter firmware leads to transmissi |
| Nova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure certain gases in blood, serum, plasma or pH of blood,Class IISep 18, 2023Potential risk of reporting erroneous creatinine patient res |
| Nova Biomedical Prime Plus Analyzer -Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, anClass IISep 18, 2023Potential risk of reporting erroneous creatinine patient res |